NCT03166137

Brief Summary

Viral warts are common skin conditions seen in both children and adults. Human papilloma virus is responsible for verrucae. Cutaneous manifestation of the human papillomavirus, are extremely common particularly on the hands and feet. Warts can induce hard, thickened skin, black pinpoints, pain or tenderness with significant morbidity for the patients.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

May 23, 2017

Last Update Submit

May 23, 2017

Conditions

Keywords

Warts,Laser,Cryotherapy

Outcome Measures

Primary Outcomes (1)

  • Number and size of the lesions.

    Dermoscopic evaluation

    Two months

Study Arms (2)

Carbon dioxide laser group

EXPERIMENTAL

(group A): thirty patients will be treated by application of carbon dioxide laser.

Device: Carbon dioxide laser

Cryotherapy group

ACTIVE COMPARATOR

(group B): thirty patients will be treated by cryotherapy application.

Device: Cryotherapy

Interventions

Radiation by carbon dioxide laser

Carbon dioxide laser group

Device using cooling effect

Cryotherapy group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with common warts male or females any age.
  • Patient is able to read and understand English and will give written informed consent to participate.
  • Patient elects to undergo carbon dioxide laser therapy or cryotherapy for treatment of common warts.
  • Warts to be treated will be located only on the hands.

You may not qualify if:

  • Non cooperative patients.
  • Patients on other lines of treatment.
  • Pregnant and lactating females.
  • Patients receiving topical treatment in the previous two weeks.
  • Secondary infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Vlahovic TC, Khan MT. The Human Papillomavirus and Its Role in Plantar Warts: A Comprehensive Review of Diagnosis and Management. Clin Podiatr Med Surg. 2016 Jul;33(3):337-53. doi: 10.1016/j.cpm.2016.02.003. Epub 2016 Mar 29.

  • Kwok CS, Gibbs S, Bennett C, Holland R, Abbott R. Topical treatments for cutaneous warts. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD001781. doi: 10.1002/14651858.CD001781.pub3.

  • Andrews MD. Cryosurgery for common skin conditions. Am Fam Physician. 2004 May 15;69(10):2365-72.

  • Zalaudek I, Giacomel J, Cabo H, Di Stefani A, Ferrara G, Hofmann-Wellenhof R, Malvehy J, Puig S, Stolz W, Argenziano G. Entodermoscopy: a new tool for diagnosing skin infections and infestations. Dermatology. 2008;216(1):14-23. doi: 10.1159/000109353.

MeSH Terms

Conditions

Warts

Interventions

Lasers, GasCryotherapy

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and SuppliesTherapeutics

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 25, 2017

Study Start

August 1, 2017

Primary Completion

August 1, 2018

Study Completion

August 1, 2019

Last Updated

May 25, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share